DK3071235T3 - Glycan-terapeutiske midler og relaterede fremgangsmåder deraf - Google Patents

Glycan-terapeutiske midler og relaterede fremgangsmåder deraf Download PDF

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DK3071235T3
DK3071235T3 DK16704085.6T DK16704085T DK3071235T3 DK 3071235 T3 DK3071235 T3 DK 3071235T3 DK 16704085 T DK16704085 T DK 16704085T DK 3071235 T3 DK3071235 T3 DK 3071235T3
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glycan
composition
glycans
ppm
preparation
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Maltzahn Geoffrey A Von
Jared Silverman
Jack Milwid
John M Geremia
Yvonne J Yamanaka
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Kaleido Biosciences Inc
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Claims (20)

1. Farmaceutisk sammensætning til anvendelse i forebyggelse af et tilbagefald af en Clostridium c//777c//e-infektion hos et menneskeligt individ tidligere administreret et lægemiddel til behandlingen afen C. difficile-infektion, hvilken sammensætning omfatter et glycan-terapeutisk præparat i en mængde effektiv til at forhindre tilbagefaldet, hvor i) det glycan-terapeutiske præparat omfatter en blanding af forgrenede glycaner, hvor den gennemsnitlige forgreningsgrad (DB) af glycanerne i præparatet er mindst 0,01; ii) mindst 50 % af glycanerne i præparatet har en polymeriseringsgrad (DP) på mindst 3 og mindre end 30 glycan-enheder; og iii) forholdet af alpha- til beta-glycosidbindinger til stede i glycanerne er mellem omkring 1:1 til omkring 5:1.
2. Sammensætningen til anvendelse ifølge krav 1, hvor: (i) tilbagefaldet omfatter tilbagevenden af et eller flere symptomer associeret med en C. c//777c/'/e-infektion; og/eller (ii) tilbagefaldet sker under eller efter en primær- eller standardlægemiddel behandlingsplan.
3. Sammensætningen til anvendelse ifølge et hvilket som helst af kravene 1-2, hvor lægemidlet til behandlingen af en C. difficile-infektion er et antibiotikum, hvor antibiotikummet eventuelt er valgt fra gruppen af vancomycin, metronidazol og fidaxomicin.
4. Sammensætningen til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor sammensætningen administreres samtidigt eller efter administration af lægemidlet til behandlingen afen C. difficile-infektion.
5. Fremgangsmåde til fremstilling afen farmaceutisk sammensætning, hvilken fremgangsmåde omfatter: (a) at tilvejebringe et præparat omfattende en blanding af syntetiske glycaner, (b) at opnå en værdi for de følgende karakteristika af præparatet: (i) polymeriseringsgraden (DP), (ii) den gennemsnitlige forgreningsgrad (DB), (iii) forholdet af alpha- glycosid til beta-glycosidbindinger, og (c) at formulere præparatet som en farmaceutisk sammensætning hvis de følgende kriterier er opfyldt: (i) mindst 50 % af glycanerne i præparatet har en DP på mindst 3 og mindre end 30 glycan-enheder, (ii) den gennemsnitlige forgreningsgrad (DB) af glycanerne i præparatet er mindst 0,01, (iii) forholdet af alpha- til beta-glycosidbindinger til stede i glycanerne af præparatet er mellem omkring 1:1 til omkring 5:1.
6. Fremgangsmåden ifølge krav 5, yderligere omfattende: b) at opnå en værdi for et hvilket som helst eller begge af de følgende yderligere karakteristika af præparatet: (iv) identiteten af glycan-enhederne, (v) forholdet af glycan-enheder, og c) at formulere præparatet som en farmaceutisk sammensætning hvis: (vi) glycan-enhedsforholdet i præparatet er omkring det samme som forholdet af glycan-enhedsinputtet.
7. Fremgangsmåden ifølge et hvilket som helst af kravene 5-6, yderligere omfattende: b) at opnå en værdi for et hvilket som helst eller begge yderligere karakteristika af præparatet: (iv) niveauet af bakterievækst, i medie suppleret med præparatet, af kommensal-stammer valgt fra gruppen bestående af Bacteroides caccae ATCC 43185, Prevotella copri DSM 18205, Bacteroides thetaiotamicron ATCC 29741, Bacteroides cellulosilyticus DSM 14838, Clostridium scindens ATCC 35704, Ruminococcus obeum ATCC 29714, Clostridium nexile ATCC 27757, og Parabacteroides distasonis ATCC 8503, (v) niveauet af bakterievækst, i medie suppleret med præparatet, af patogene stammer valgt fra gruppen bestående af Clostridium difficile ATCC BAA-1382, Clostridium difficile ATCC 43255, Enterococcus faecium ATCC 700221, og Salmonella enterica ATCC 27869, og c) at formulere præparatet som en farmaceutisk sammensætning hvis et eller begge af de følgende kriterier er opfyldt: (vi) promovering af mediet suppleret med vækstpræparatet på mindst 5 kommensal-stammer, (v) promovering af mediet suppleret med vækstpræparatet på ikke mere end 2 patogene stammer.
8. Fremgangsmåden ifølge et hvilket som helst af kravene 6-7, hvor trin (b) udføres forud for, samtidigt med eller efter trin (b) ifølge krav 5, men forud for trin (c) ifølge krav 5.
9. Fremgangsmåden ifølge et hvilket som helst af kravene 5-8, hvor trinnet at formulere præparatet som en farmaceutisk sammensætning omfatter en eller flere af: i) at fjerne uønskede bestanddele fra præparatet, ii) at reducere volumen af præparatet, iii) at sterilisere præparatet, iv) at blande præparatet med en farmaceutisk acceptabel excipiens eller bærer, v) at blande præparatet med et andet lægemiddel eller farmaceutisk middel, vi) at formulere præparatet til en vandig opløsning eller sirup, vii) at formulere præparatet til en tablet eller pille, viii) at formulere præparatet til en kapsel, ix) at emballere præparatet, x) at markere det emballerede præparat af ix), og xi) at sælge eller sætte det emballerede og markerede præparat af x) til salg.
10. Fremgangsmåden ifølge krav 5, fremgangsmåden omfattende: (i) at tilvejebringe et terapeutisk glycan-præparat omfattende mindst en glycan-enhed valgt fra gruppen bestående af glucose, galaktose, fucose, xylose, arabinose, rhamnose, og mannose, (ii) at bestemme om en forvalgt NMR-top eller gruppe af NMR-toppe er associeret med glycan-præparatet, og (iii) hvis den forvalgte top eller gruppe af toppe er til stede, at formulere præparatet som en farmaceutisk sammensætning.
11. Fremgangsmåden ifølge krav 10, hvor toppen er en 1H-13C HSQC NMR-top, og hvor bestemmelsen eventuelt omfatter: at opnå en værdi for identiteten af en 1H-13C HSQC-top eller gruppe af toppe associeret med præparatet, og hvis en forvalgt top er til stede, at formulere præparatet som en farmaceutisk sammensætning.
12. Fremgangsmåden ifølge et hvilket som helst af kravene 10-11, hvor (i) for glycaner omfattende glucose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.42, 92.5; 5.21, 92.8; 5.18, 93.9; 5.08, 97.0; 5.36, 98.4; 5.34, 99.8; 5.38, 100.3; 4.95, 98.6; 4.62, 96.6; 4.70, 103.6; 4.49, 103.4 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (ii) for glycaner omfattende galaktose, toppene omfatter mindst en 1H-13C HSQC-top valgt fra 5.37, 92.9; 5.24, 93.1; 5.14, 96.0; 4.96, 99.3; 5.31, 98.7; 5.39, 101.4; 5.00, 101.8; 4.80, 101.3; 4.63, 97.0; 4.56, 97.2; 4.53, 103.1; 4.43, 104.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (iii) for glycaner omfattende fucose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.18, 92.9; 5.33, 92.4; 5.04, 96.3; 4.90, 99.7; 4.52, 97.0; 4.39, 103.6 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (iv) for glycaner omfattende xylose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.18, 93.0; 5.10, 94.3; 5.34, 98.2; 5.31, 99.6; 5.11, 100.8; 4.91, 99.4; 4.56, 97.3; 4.64, 104.2; 4.54, 103.4; 4.44, 102.6; 4.44, 104.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (v) for glycaner omfattende arabinose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.22, 93.2; 5.13, 93.2; 5.29, 96.0; 5.26, 97.2; 5.12, 96.6; 5.18, 99.6; 5.06, 99.2; 4.99, 100.0; 5.26, 101.9; 5.06, 102.1; 4.55, 97.4; 4.54, 105.2; 4.50, 105.5; 4.38, 103.9 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (vi) for glycaner omfattende rhamnose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.21, 93.2; 5.10, 94.5; 4.85, 94.1; 5.01, 95.8; 5.35, 100.5; 5.15, 102.2; 5.04, 102.9; 4.78, 97.9; 4.71, 99.0; 4.72, 101.0 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (vii) for glycaner omfattende mannose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.37, 93.0; 5.16, 94.6; 4.88, 94.2; 5.39, 101.7; 5.24, 101.9; 5.13, 102.8; 5.03, 102.7; 5.24, 105.6; 5.09, 108.0; 4.88, 94.2; 4.89, 100.0; 4.70, 101.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top.
13. Farmaceutisk sammensætning omfattende et terapeutisk glycan-præparat omfattende en blanding af forgrenede glycaner, hvor den gennemsnitlige forgreningsgrad (DB) af glycanerne i præparatet er mindst 0,01, hvor i) mindst 50 % af glycanerne i præparatet har en polymeriseringsgrad (DP) på mindst 3 og mindre end 30 glycan-enheder, ii) glycan-præparatet omfatter både alpha- og beta-glycosidbindinger, iii) mindst en af glycosidbindingerne til stede i glycanerne af præparatet omfatter en l->2 glycosidbinding, en l->3 glycosidbinding, en l->4 glycosidbinding, eller en l->6 glycosidbinding, og iv) forholdet af alpha- til beta-glycosidbindinger til stede i glycanerne af præparatet er mellem omkring 1:1 til omkring 5:1.
14. Sammensætningen ifølge krav 13, hvor mindst to eller mindst tre af glycosidbindingerne uafhængigt omfatter en l->2 glycosidbinding, en l->3 glycosidbinding, en l->4 glycosidbinding, eller en l->6 glycosidbinding.
15. Sammensætningen ifølge et hvilket som helst af kravene 13-14, hvor glycan-enhederne omfatter mindst en af et monosaccharid valgt fra gruppen af glucose, galaktose, arabinose, mannose, fruktose, xylose, fucose, og rhamnose.
16. Sammensætningen ifølge et hvilket som helst af kravene 13-15, hvor det glycan-terapeutiske præparat er syntetisk og ikke isoleret fra en naturlig oligosaccharid- eller polysaccharidkilde.
17. Sammensætningen ifølge et hvilket som helst af kravene 13-16, yderligere omfattende en eller flere af (i) et polyphenol-præparat; (ii) et præparat af probiotiske bakterier; (iii) et lægemiddel eller terapeutisk middel; og (iv) en farmaceutisk acceptabel excipiens.
18. Sammensætningen ifølge et hvilket som helst af kravene 13-17, hvor sammensætningen er formuleret som en enhedsdosisform, og hvor eventuelt: (i) enhedsdosisformen er formuleret til oral indgivelse; eller (ii) enhedsdosisformen er formuleret til at opløses i en vandig opløsning og er oralt administreret som en drikkevare, sirup, opløsning eller suspension.
19. Den farmaceutiske sammensætning ifølge krav 13 omfattende mindst en glycan-enhed valgt fra gruppen af: glucose, galaktose, fucose, xylose, arabinose, rhamnose, og mannose, hvor præparatet omfatter en glycan-enhed associeret med en, to eller flere af de følgende 1H-13C HSQC-toppe: (i) for glycaner omfattende glucose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.42, 92.5; 5.21, 92.8; 5.18, 93.9; 5.08, 97.0; 5.36, 98.4; 5.34, 99.8; 5.38, 100.3; 4.95, 98.6; 4.62, 96.6; 4.70, 103.6; 4.49, 103.4 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (ii) for glycaner omfattende galaktose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.37, 92.9; 5.24, 93.1; 5.14, 96.0; 4.96, 99.3; 5.31, 98.7; 5.39, 101.4; 5.00, 101.8; 4.80, 101.3; 4.63, 97.0; 4.56, 97.2; 4.53, 103.1; 4.43, 104.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (iii) for glycaner omfattende fucose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.18, 92.9; 5.33, 92.4; 5.04, 96.3; 4.90, 99.7; 4.52, 97.0; 4.39, 103.6 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (iv) for glycaner omfattende xylose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.18, 93.0; 5.10, 94.3; 5.34, 98.2; 5.31, 99.6; 5.11, 100.8; 4.91, 99.4; 4.56, 97.3; 4.64, 104.2; 4.54, 103.4; 4.44, 102.6; 4.44, 104.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (v) for glycaner omfattende arabinose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.22, 93.2; 5.13, 93.2;5.29, 96.0; 5.26, 97.2; 5.12, 96.6; 5.18, 99.6; 5.06, 99.2; 4.99, 100.0; 5.26, 101.9; 5.06, 102.1; 4.55, 97.4; 4.54, 105.2; 4.50, 105.5; 4.38, 103.9 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (vi) for glycaner omfattende rhamnose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.21, 93.2; 5.10, 94.5; 4.85, 94.1; 5.01, 95.8; 5.35, 100.5; 5.15, 102.2; 5.04, 102.9; 4.78, 97.9; 4.71, 99.0; 4.72, 101.0 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top; (vii) for glycaner omfattende mannose, toppene omfatter mindst en eller mindst to 1H-13C HSQC-toppe valgt fra 5.37, 93.0; 5.16, 94.6; 4.88, 94.2; 5.39, 101.7; 5.24, 101.9; 5.13, 102.8; 5.03, 102.7; 5.24, 105.6; 5.09, 108.0; 4.88, 94.2; 4.89, 100.0; 4.70, 101.1 IH skift (ppm) og 13C skift (ppm) eller en tilsvarende top.
20. Farmaceutisk kit omfattende: i) den farmaceutiske sammensætning ifølge et hvilket som helst af kravene 13-19, ii) mindst en anden bestanddel valgt fra gruppen af et præparat af polyphenoler, et præparat af probiotiske bakterier, et lægemiddel eller terapeutisk middel, og en kosttilskuds-komponent, i) instruktionsmateriale, og ii) emballage.
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